Trial · NCT07538258
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Investigator-Assessed Objective Response Rate | Baseline at screening, after every 2 treatment cycles (each cycle is 21 days), end of treatment, up to disease progression, assessed up to approximately 24 months | According to RECIST 1.1 criteria, investigator assesses target lesion changes via imaging; calculates the proportion of subjects achieving complete response (CR) or partial response (PR) |
| Secondary | Serious Adverse Event (SAE) | from date of first study drug administration, follow-up until resolution or stabilization, assessed up to approximately 24 months | Collect SAEs resulting in death, life-threatening condition, hospitalization, disability per CTCAE 5.0 and ICH-GCP, document and report |
| Secondary | 6-Month Progression-Free Survival Rate | 6-month time point after first treatment, follow-up cutoff | Estimated proportion of subjects without progression and alive at 6 months after first treatment using Kaplan-Meier method |
| Secondary | Immune-Related Adverse Event (irAE) | From date of first study drug administration through 90 days after the last dose of study drug; assessed at baseline, each cycle visit, and unscheduled visits for suspected irAEs; graded per CTCAE 5.0 and irAE-specific criteria. | Identify and grade organ-specific immune-related adverse events according to CTCAE 5.0 and irAE criteria |
| Secondary | Progression-Free Survival (PFS) | From date of first study drug administration until the date of first documented disease progression (per RECIST v1.1) or death from any cause, whichever occurs first; assessed up to 24 months (maximum follow-up period). | Time from first treatment to disease progression or death from any cause, whichever occurs first |
| Secondary | 18-Month Overall Survival Rate | 18-month time point after first treatment, follow-up cutoff | Estimated proportion of alive subjects at 18 months after first treatment via Kaplan-Meier method |
| Secondary | 12-Month Overall Survival Rate | 12-month time point after first treatment, follow-up cutoff | Estimated proportion of alive subjects at 12 months after first treatment using Kaplan-Meier method |
| Secondary | 12-Month Progression-Free Survival Rate | 12-month time point after first treatment, follow-up cutoff | Estimated proportion of progression-free and alive subjects at 12 months via Kaplan-Meier method |
| Secondary | Overall Survival (OS) | From date of first study treatment to date of death from any cause or last follow-up, whichever occurs first, assessed up to approximately 24 months | Time from first study treatment to death from any cause; censored at last follow-up for alive subjects |
| Secondary | Disease Control Rate (DCR) | Time Frame: Baseline and after every 2 treatment cycles (each cycle is 21 days), up to disease progression, death, or study withdrawal, whichever occurs first，assessed up to approximately 24 months | According to RECIST 1.1, proportion of subjects achieving CR, PR, or stable disease (SD) in total enrolled population |
| Secondary | Duration of Response (DOR) | From date of first confirmed objective response (CR/PR) until date of disease progression, death from any cause, or initiation of new antitumor therapy, whichever occurs first, assessed up to approximately 24 months | Time from first confirmed CR/PR to disease progression, death from any cause, or initiation of new antitumor therapy |
| Secondary | Adverse Event (AE) | From signing informed consent through study completion and safety follow-up, assessed up to approximately 24 months | Record all new or worsening unfavorable medical events, grade and calculate incidence according to CTCAE 5.0 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT07538258/registered